New Rx Stalls Advanced Lung Cancer

Gilotrif receives FDA approval for late stage non small cell lung cancer

(RxWiki News) Lung cancer isn’t a single disease. Changes in genes produce different versions of lung cancer — the most common cancer in the US. Now there's a new medication designed to treat one specific type of lung cancer.

The US Food and Drug Administration (FDA) has approved a new therapy for advanced non-small cell lung cancer (NSCLC).

Gilotrif (afatinib) will be available to treat NSCLC that has epidermal growth factor receptor (EGFR) gene mutations.

The FDA has also approved a companion test that analyzes NSCLC tumors for EGFR mutations.

"Talk to your oncologist about genetic testing."

NSCLC is the most common type of lung cancer, and will be diagnosed in about 228,000 Americans this year. Approximately 10 percent of these cancers have an EGFR mutation.

Gilotrif attacks a protein that’s involved in the development of cancer. The new oral medication is intended for patients who have specific mutations — EGFR exon 19 deletions or exon 21 L858R substitutions.

Deletions and substitutions are types of mutations that occur in DNA.

A new test that identifies these specific genetic changes has also been approved by the FDA. It’s called the therascreen EGFR RGQ PCR Kit and is designed to spot EGFR mutations.

This is the second medication that’s been approved this year for advanced NSCLC. Earlier in the year, the FDA approved Tarceva (erlotinib) for first-line treatment of patients with NSCLC, along with the cobas EGFR Mutation Test.

"The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

The approval of Gilotrif is based on a study involving 345 participants with metastatic (has spread) NSCLC whose tumors had EGFR mutations.

Compared to six rounds of standard chemotherapy, patients treated with Gilotrif had a 4.2 month span before the cancer got worse. This period in which the cancer does not get worse is called progression-free survival.

The medication did not impact overall survival.

"Afatinib is another option for first-line therapy for patients with non-small cell lung cancer with EGRF mutations," lung cancer specialist Fred R. Hirsch, MD, PhD, told dailyRx News.

"The trial not only clearly showed superiority over standard chemotherapy, but also improved lung cancer symptoms [cough, shortness of breath], which is also very important," said Dr. Hirsch, who is professor of medicine and pathology at the University of Colorado Cancer Center.

Common side effects of Gilotrif include diarrhea, skin breakouts that resemble acne, dry skin, itching, mouth inflammation, skin infection around the nails, decreased appetite, decreased weight, bladder inflammation, nose bleed, runny nose, fever, eye inflammation and low potassium levels in the blood.

Serious side effects include diarrhea that can result in kidney failure and severe dehydration, severe rash, lung inflammation and liver toxicity. 

Gilotrif was reviewed under the FDA’s priority review program, which speeds up the review for medications that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
Gilotrif is marketed by Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Connecticut. The therascreen EGFR RGQ PCR Kit is manufactured by QIAGEN Manchester Ltd., based in the United Kingdom.

Review Date: 
July 12, 2013